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GE180 has limited Blood - brain barrier permeation, reducing its utility in neuroinflammation. COVID19 created supply chain issues, impacting enrollment.
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The complex pathological cascades leading to both Alzheimer's disease (AD) and Parkinson's disease (PD) involve, at various points, inflammation. Since inflammation is a treatable symptom, understanding how and when it impacts the brain, and where specifically in the brain, would offer important guidance in the development of new treatments, sorely needed in both diseases.
Microglia play an important anti-inflammatory role, and produce a substance, mitochondrial translocator protein (TSPO), whose presence can be used as a marker of regional inflammation. GE180 is a newly developed PET ligand which binds to TSPO and hence can be used in imaging studies to analyze regional inflammation in living patients. In prior studies it has shown regional specificity in multiple sclerosis and brain injury. In the current study, the investigators will be using GE180 to analyze regional and global inflammation in the brains of patients with AD and PD at a single time point.
The results of the current study will provide enriched understanding of inflammation in these conditions, and potentially provide preliminary data to inform design of future interventional trials.
This study will involve a cohort that is currently being established at the Cleveland Clinic Lou Ruvo Center for Brain Health. The cohort has been established under the NIH Center of Biomedical Research Excellence (COBRE) grant and involves annual collection of detailed neuropsychological testing and biomarkers (blood and neuroimaging) from all participants annually. Data are filed in a registry (CNTN). Participants include healthy controls, participants with PD (with and without mild cognitive impairment (MCI)) and patients with MCI (with or without positive florbetapir scan, which demonstrates underlying AD changes likely causing the cognitive impairment) and patients with AD. For the current study, we will focus on patients with MCI with associated underlying AD or PD.
Participants will undergo GE180 PET one time during the study. The approach to PET data collection and analysis will be similar to work done previously with an earlier generation ligand (Edison et al., 2008) and to other work with this tracer (Fan et al., 2016). Participants will complete ECGs and have their vitals taken prior to and immediately following injections. Briefly, the ligand will be injected, there will be a 90 minute uptake period, and scan acquisition will commence for 30 minutes, and will be collected in list mode and rebinned into 18 time frames post acquisition.
The total duration of the study visit will be around 4 hours, and the participants will receive $50 compensation for the visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alzheimer's Disease | Experimental | Alzheimer's Disease GE180 PET Scan |
|
| Parkinson's Disease | Experimental | Parkinson's Disease GE180 PET Scan |
|
| Control | Experimental | Control Group GE180 PET Scan |
|
| Mild Cognitive Impairment | Experimental | Mild Cognitive Impairment GE180 PET Scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GE180 PET Scan | Drug | GE180 PET Scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frontal GE180 Standardized Uptake Value Ratio (SUVR) | Frontal SUVR- GE180 binding potential in the frontal cortical ROI, as a marker of frontal neuroinflammation. Frontal neuroinflammation would be expected to relate to frontal lobe AD pathology, and given known frontal lobe role in executive system function, is hypothesized to relate to measures of executive function in particular, and also to memory and language dysfunction, as these have executive components. Greater frontal lobe GE180 is expected to relate to poorer cognitive function. | Baseline (Single scan) |
| Cingulate GE180 Standardized Uptake Value Ratio (SUVR) | Cingulate SUVR- GE180 binding potential in the cingulate ROI, as a marker of cingulate neuroinflammation. Cingulate neuroinflammation would be expected to relate to cingulate AD pathology, and given known cingulate lobe role in executive system function, is hypothesized to relate to measures of executive function in particular, with greater cingulate GE180 relating to poorer cognitive function. | Baseline (Single scan) |
| Parietal GE180 Standardized Uptake Value Ratio (SUVR) | Parietal SUVR - GE180 binding potential in the parietal cortical ROI, as a marker of parietal neuroinflammation. Parietal neuroinflammation would be expected to relate to parietal lobe AD pathology, and given known parietal lobe role in visual and executive system function, is hypothesized to relate to measures of visuospatial and executive skills in particular, with greater parietal lobe GE180 relating to poorer cognitive function. | Baseline (Single scan) |
| Temporal GE180 Standardized Uptake Value Ratio (SUVR) | Temporal SUVR-- GE180 binding potential in the temporal cortical ROI, as a marker of temporal neuroinflammation. Temporal neuroinflammation would be expected to relate to temporal lobe AD pathology, and given known temporal lobe role in memory and language system function, is hypothesized to relate to measures of memory in particular, with greater temporal lobe GE180 relating to poorer memory and language function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron R Ritter, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lou Ruvo Center for Brain Health | Las Vegas | Nevada | 89106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25833819 | Background | Maphis N, Xu G, Kokiko-Cochran ON, Jiang S, Cardona A, Ransohoff RM, Lamb BT, Bhaskar K. Reactive microglia drive tau pathology and contribute to the spreading of pathological tau in the brain. Brain. 2015 Jun;138(Pt 6):1738-55. doi: 10.1093/brain/awv081. Epub 2015 Mar 31. | |
| 16953112 | Background | Kim YS, Joh TH. Microglia, major player in the brain inflammation: their roles in the pathogenesis of Parkinson's disease. Exp Mol Med. 2006 Aug 31;38(4):333-47. doi: 10.1038/emm.2006.40. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Control Group GE180 PET Scan, 2 μg/mL IV, 185MBq |
| FG001 | Mild Cognitive Impairment | Mild Cognitive Impairment GE180 PET Scan, 2 μg/mL IV, 185MBq |
| FG002 | Alzheimer's Disease | Alzheimer's Disease GE180 PET Scan, 2 μg/mL IV, 185MBq |
| FG003 | Parkinson's Disease | Parkinson's Disease GE180 PET Scan, 2 μg/mL IV, 185MBq |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | Control Group GE180 PET Scan, 2 μg/mL IV, 185MBq |
| BG001 | Mild Cognitive Impairment | Mild Cognitive Impairment GE180 PET Scan, 2 μg/mL IV, 185MBq |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frontal GE180 Standardized Uptake Value Ratio (SUVR) | Frontal SUVR- GE180 binding potential in the frontal cortical ROI, as a marker of frontal neuroinflammation. Frontal neuroinflammation would be expected to relate to frontal lobe AD pathology, and given known frontal lobe role in executive system function, is hypothesized to relate to measures of executive function in particular, and also to memory and language dysfunction, as these have executive components. Greater frontal lobe GE180 is expected to relate to poorer cognitive function. | Posted | Mean | Standard Deviation | SUVR | Baseline (Single scan) |
|
24 hours
There was no anticipated risk of mortality (all-causes) during the course of the project.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Control Group GE180 PET Scan, 2 μg/mL IV, 185MBq | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low-Grade Headache | Nervous system disorders | Systematic Assessment |
Limitations of the data presented here include reduced power in the statistical analysis due to reduced enrollment, and should be reviewed in the context of recent data related to the blood-brain barrier permeability of GE180.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron Ritter, MD | Cleveland Clinic | 17024836000 | rittera@ccf.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2020 | Jan 3, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D010300 | Parkinson Disease |
| D007249 | Inflammation |
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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All participants will receive one Flutriciclamide (18F-GE180) PET scan.
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No masking
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| Baseline (Single scan) |
| Whole Brain GE180 Standardized Uptake Value Ratio (SUVR) | Whole Brain GE180- GE180 binding potential in the whole brain, as a marker of global neuroinflammation. Global neuroinflammation would be expected to relate to more widespread pathology on average, and is hypothesized to relate to global measures of cognition, including the MoCA and DRS, with greater whole brain GE180 relating to poorer cognitive function overall. | Baseline (Single scan) |
| Memory Composite Score (Z-score) | The memory composite score is comprised from data from two gold-standard clinical measures of verbal and nonverbal memory (Rey Auditory Verbal Learning Test, delayed recall score; Brief Visuospatial Memory Test, Revised, delayed recall score). The raw score for each individual assessment is corrected for age based on published normative data for each test. These adjusted scores (T scores and/or scaled scores) are converted to z-scores, then the two z-scores are averaged together to create the composite score. A higher value is indicative of better memory function, a lower value is indicative of worse memory function. A z-score of 0 represents the sample mean. Composite Z-scores do not have direct clinical relevance. | Baseline (Pre-scan) |
| Executive Function Composite Score (Z-score) | The executive function composite score is comprised from data from two gold-standard clinical measures of set-shifting and inhibition (Trail Making Test, part B; Delis Kaplan Executive Functioning Scale Color Word Inhibition, inhibition score). The raw score for each individual assessment is corrected for age based on published normative data for each test. These adjusted scores (T scores and/or scaled scores) are converted to z-scores, then the two z-scores are averaged together to create the composite score. A higher value is indicative of better executive function, a lower value is indicative of worse executive function. A z-score of 0 represents the sample mean. Composite Z-scores do not have direct clinical relevance. | Baseline (Pre-scan) |
| Speed Composite Score (Z-score) | The speed composite score is comprised from data from two gold-standard clinical measures of speeded attention and psychomotor speed (Trail Making Test, part A; Symbol Digit Modalities Test, oral version). The raw score for the Symbol Digit Modalities Test, oral version is converted directly to a z-score based on published normative data. The Trail making Test, part A is corrected for age based on published normative data, resulting in a T-score, which is then converted to a z-score. Then the two z-scores are averaged together to create the composite score. A higher value is indicative of better speed function, a lower value is indicative of worse speed function. A z-score of 0 represents the sample mean. Composite Z-scores do not have direct clinical relevance. | Baseline (Pre-scan) |
| Language Composite Score (Z-score) | The language composite score is comprised from data from two gold-standard clinical measures of confrontation naming and semantic fluency (Boston Naming Test; Animal Naming Test). The raw score for the Animal Naming Test is converted directly to a z-score based on published normative data. The Boston Naming Test is corrected for age based on published normative data, resulting in a scaled score, which is then converted to a z-score. Then the two z-scores are averaged together to create the composite score. A higher value is indicative of better language function, a lower value is indicative of worse language function. A z-score of 0 represents the sample mean. Composite Z-scores do not have direct clinical relevance. | Baseline (Pre-scan) |
| Dementia Rating Score | DRS- The Dementia Rating Scale is a comprehensive, but relatively brief assessment of overall cognitive functioning. The measure consists of items testing memory, attention, executive skills, and visuospatial skill, for a total of 144 points. A score of less than 124 is indicative of dementia level cognitive functioning. A higher score indicates a better outcome. | Baseline (Pre-scan) |
| Montreal Cognitive Assessment Score (MoCA) | MoCA -The Montreal Cognitive Assessment is a brief screening tool, originally designed to detect patients with MCI in a memory disorders clinic [10]. Standard administration consists of 12 individual tasks grouped into seven cognitive domains (visuospatial/executive, naming; attention, language, abstraction, memory, and orientation). Task performance is summed generating both domain and a total score. An education correction of one point is added to the total score for individuals with 12 years of education or less. Scores range from 0-30, with a score of 26 or less indicating cognitive impairment. | Baseline (Pre-scan) |
| 24303218 | Background | Ji K, Miyauchi J, Tsirka SE. Microglia: an active player in the regulation of synaptic activity. Neural Plast. 2013;2013:627325. doi: 10.1155/2013/627325. Epub 2013 Nov 3. |
| 2891401 | Background | Benavides J, Fage D, Carter C, Scatton B. Peripheral type benzodiazepine binding sites are a sensitive indirect index of neuronal damage. Brain Res. 1987 Sep 22;421(1-2):167-72. doi: 10.1016/0006-8993(87)91287-x. |
| 27261523 | Background | Fan Z, Calsolaro V, Atkinson RA, Femminella GD, Waldman A, Buckley C, Trigg W, Brooks DJ, Hinz R, Edison P. Flutriciclamide (18F-GE180) PET: First-in-Human PET Study of Novel Third-Generation In Vivo Marker of Human Translocator Protein. J Nucl Med. 2016 Nov;57(11):1753-1759. doi: 10.2967/jnumed.115.169078. Epub 2016 Jun 3. |
| 18828015 | Background | Chauveau F, Boutin H, Van Camp N, Dolle F, Tavitian B. Nuclear imaging of neuroinflammation: a comprehensive review of [11C]PK11195 challengers. Eur J Nucl Med Mol Imaging. 2008 Dec;35(12):2304-19. doi: 10.1007/s00259-008-0908-9. Epub 2008 Oct 1. |
| 25351507 | Background | Boutin H, Murray K, Pradillo J, Maroy R, Smigova A, Gerhard A, Jones PA, Trigg W. 18F-GE-180: a novel TSPO radiotracer compared to 11C-R-PK11195 in a preclinical model of stroke. Eur J Nucl Med Mol Imaging. 2015 Mar;42(3):503-11. doi: 10.1007/s00259-014-2939-8. Epub 2014 Oct 29. |
| 26609163 | Background | Liu B, Le KX, Park MA, Wang S, Belanger AP, Dubey S, Frost JL, Holton P, Reiser V, Jones PA, Trigg W, Di Carli MF, Lemere CA. In Vivo Detection of Age- and Disease-Related Increases in Neuroinflammation by 18F-GE180 TSPO MicroPET Imaging in Wild-Type and Alzheimer's Transgenic Mice. J Neurosci. 2015 Nov 25;35(47):15716-30. doi: 10.1523/JNEUROSCI.0996-15.2015. |
| 27179961 | Background | Calsolaro V, Edison P. Neuroinflammation in Alzheimer's disease: Current evidence and future directions. Alzheimers Dement. 2016 Jun;12(6):719-32. doi: 10.1016/j.jalz.2016.02.010. Epub 2016 May 11. |
| 18786637 | Background | Edison P, Archer HA, Gerhard A, Hinz R, Pavese N, Turkheimer FE, Hammers A, Tai YF, Fox N, Kennedy A, Rossor M, Brooks DJ. Microglia, amyloid, and cognition in Alzheimer's disease: An [11C](R)PK11195-PET and [11C]PIB-PET study. Neurobiol Dis. 2008 Dec;32(3):412-9. doi: 10.1016/j.nbd.2008.08.001. Epub 2008 Aug 15. |
| 22008728 | Background | Owen DR, Yeo AJ, Gunn RN, Song K, Wadsworth G, Lewis A, Rhodes C, Pulford DJ, Bennacef I, Parker CA, StJean PL, Cardon LR, Mooser VE, Matthews PM, Rabiner EA, Rubio JP. An 18-kDa translocator protein (TSPO) polymorphism explains differences in binding affinity of the PET radioligand PBR28. J Cereb Blood Flow Metab. 2012 Jan;32(1):1-5. doi: 10.1038/jcbfm.2011.147. Epub 2011 Oct 19. |
| 20844871 | Background | Yokokura M, Mori N, Yagi S, Yoshikawa E, Kikuchi M, Yoshihara Y, Wakuda T, Sugihara G, Takebayashi K, Suda S, Iwata Y, Ueki T, Tsuchiya KJ, Suzuki K, Nakamura K, Ouchi Y. In vivo changes in microglial activation and amyloid deposits in brain regions with hypometabolism in Alzheimer's disease. Eur J Nucl Med Mol Imaging. 2011 Feb;38(2):343-51. doi: 10.1007/s00259-010-1612-0. Epub 2010 Sep 16. |
| 24516258 | Background | Dickens AM, Vainio S, Marjamaki P, Johansson J, Lehtiniemi P, Rokka J, Rinne J, Solin O, Haaparanta-Solin M, Jones PA, Trigg W, Anthony DC, Airas L. Detection of microglial activation in an acute model of neuroinflammation using PET and radiotracers 11C-(R)-PK11195 and 18F-GE-180. J Nucl Med. 2014 Mar;55(3):466-72. doi: 10.2967/jnumed.113.125625. Epub 2014 Feb 10. |
| 26551697 | Background | Turkheimer FE, Rizzo G, Bloomfield PS, Howes O, Zanotti-Fregonara P, Bertoldo A, Veronese M. The methodology of TSPO imaging with positron emission tomography. Biochem Soc Trans. 2015 Aug;43(4):586-92. doi: 10.1042/BST20150058. Epub 2015 Aug 3. |
| 24667911 | Background | Rizzo G, Veronese M, Tonietto M, Zanotti-Fregonara P, Turkheimer FE, Bertoldo A. Kinetic modeling without accounting for the vascular component impairs the quantification of [(11)C]PBR28 brain PET data. J Cereb Blood Flow Metab. 2014 Jun;34(6):1060-9. doi: 10.1038/jcbfm.2014.55. Epub 2014 Mar 26. |
| BG002 | Alzheimer's Disease | Alzheimer's Disease GE180 PET Scan, 2 μg/mL IV, 185MBq |
| BG003 | Parkinson's Disease | Parkinson's Disease GE180 PET Scan, 2 μg/mL IV, 185MBq |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Mild Cognitive Impairment
GE180 PET Scan, 2 μg/mL IV, 185MBq
| OG002 | Alzheimer's Disease | Alzheimer's Disease GE180 PET Scan, 2 μg/mL IV, 185MBq |
| OG003 | Parkinson's Disease | Parkinson's Disease GE180 PET Scan, 2 μg/mL IV, 185MBq |
|
|
|
| Primary | Cingulate GE180 Standardized Uptake Value Ratio (SUVR) | Cingulate SUVR- GE180 binding potential in the cingulate ROI, as a marker of cingulate neuroinflammation. Cingulate neuroinflammation would be expected to relate to cingulate AD pathology, and given known cingulate lobe role in executive system function, is hypothesized to relate to measures of executive function in particular, with greater cingulate GE180 relating to poorer cognitive function. | Posted | Mean | Standard Deviation | SUVR | Baseline (Single scan) |
|
|
|
|
| Primary | Parietal GE180 Standardized Uptake Value Ratio (SUVR) | Parietal SUVR - GE180 binding potential in the parietal cortical ROI, as a marker of parietal neuroinflammation. Parietal neuroinflammation would be expected to relate to parietal lobe AD pathology, and given known parietal lobe role in visual and executive system function, is hypothesized to relate to measures of visuospatial and executive skills in particular, with greater parietal lobe GE180 relating to poorer cognitive function. | Posted | Mean | Standard Deviation | SUVR | Baseline (Single scan) |
|
|
|
|
| Primary | Temporal GE180 Standardized Uptake Value Ratio (SUVR) | Temporal SUVR-- GE180 binding potential in the temporal cortical ROI, as a marker of temporal neuroinflammation. Temporal neuroinflammation would be expected to relate to temporal lobe AD pathology, and given known temporal lobe role in memory and language system function, is hypothesized to relate to measures of memory in particular, with greater temporal lobe GE180 relating to poorer memory and language function. | Posted | Mean | Standard Deviation | SUVR | Baseline (Single scan) |
|
|
|
|
| Primary | Whole Brain GE180 Standardized Uptake Value Ratio (SUVR) | Whole Brain GE180- GE180 binding potential in the whole brain, as a marker of global neuroinflammation. Global neuroinflammation would be expected to relate to more widespread pathology on average, and is hypothesized to relate to global measures of cognition, including the MoCA and DRS, with greater whole brain GE180 relating to poorer cognitive function overall. | Posted | Mean | Standard Deviation | SUVR | Baseline (Single scan) |
|
|
|
|
| Primary | Memory Composite Score (Z-score) | The memory composite score is comprised from data from two gold-standard clinical measures of verbal and nonverbal memory (Rey Auditory Verbal Learning Test, delayed recall score; Brief Visuospatial Memory Test, Revised, delayed recall score). The raw score for each individual assessment is corrected for age based on published normative data for each test. These adjusted scores (T scores and/or scaled scores) are converted to z-scores, then the two z-scores are averaged together to create the composite score. A higher value is indicative of better memory function, a lower value is indicative of worse memory function. A z-score of 0 represents the sample mean. Composite Z-scores do not have direct clinical relevance. | Posted | Mean | Standard Deviation | z score | Baseline (Pre-scan) |
|
|
|
| Primary | Executive Function Composite Score (Z-score) | The executive function composite score is comprised from data from two gold-standard clinical measures of set-shifting and inhibition (Trail Making Test, part B; Delis Kaplan Executive Functioning Scale Color Word Inhibition, inhibition score). The raw score for each individual assessment is corrected for age based on published normative data for each test. These adjusted scores (T scores and/or scaled scores) are converted to z-scores, then the two z-scores are averaged together to create the composite score. A higher value is indicative of better executive function, a lower value is indicative of worse executive function. A z-score of 0 represents the sample mean. Composite Z-scores do not have direct clinical relevance. | Posted | Mean | Standard Deviation | z score | Baseline (Pre-scan) |
|
|
|
| Primary | Speed Composite Score (Z-score) | The speed composite score is comprised from data from two gold-standard clinical measures of speeded attention and psychomotor speed (Trail Making Test, part A; Symbol Digit Modalities Test, oral version). The raw score for the Symbol Digit Modalities Test, oral version is converted directly to a z-score based on published normative data. The Trail making Test, part A is corrected for age based on published normative data, resulting in a T-score, which is then converted to a z-score. Then the two z-scores are averaged together to create the composite score. A higher value is indicative of better speed function, a lower value is indicative of worse speed function. A z-score of 0 represents the sample mean. Composite Z-scores do not have direct clinical relevance. | Posted | Mean | Standard Deviation | z score | Baseline (Pre-scan) |
|
|
|
| Primary | Language Composite Score (Z-score) | The language composite score is comprised from data from two gold-standard clinical measures of confrontation naming and semantic fluency (Boston Naming Test; Animal Naming Test). The raw score for the Animal Naming Test is converted directly to a z-score based on published normative data. The Boston Naming Test is corrected for age based on published normative data, resulting in a scaled score, which is then converted to a z-score. Then the two z-scores are averaged together to create the composite score. A higher value is indicative of better language function, a lower value is indicative of worse language function. A z-score of 0 represents the sample mean. Composite Z-scores do not have direct clinical relevance. | Posted | Mean | Standard Deviation | z score | Baseline (Pre-scan) |
|
|
|
| Primary | Dementia Rating Score | DRS- The Dementia Rating Scale is a comprehensive, but relatively brief assessment of overall cognitive functioning. The measure consists of items testing memory, attention, executive skills, and visuospatial skill, for a total of 144 points. A score of less than 124 is indicative of dementia level cognitive functioning. A higher score indicates a better outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Pre-scan) |
|
|
|
| Primary | Montreal Cognitive Assessment Score (MoCA) | MoCA -The Montreal Cognitive Assessment is a brief screening tool, originally designed to detect patients with MCI in a memory disorders clinic [10]. Standard administration consists of 12 individual tasks grouped into seven cognitive domains (visuospatial/executive, naming; attention, language, abstraction, memory, and orientation). Task performance is summed generating both domain and a total score. An education correction of one point is added to the total score for individuals with 12 years of education or less. Scores range from 0-30, with a score of 26 or less indicating cognitive impairment. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Pre-scan) |
|
|
|
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Mild Cognitive Impairment | Mild Cognitive Impairment GE180 PET Scan, 2 μg/mL IV, 185MBq | 0 | 7 | 0 | 7 | 2 | 7 |
| EG002 | Alzheimer's Disease | Alzheimer's Disease GE180 PET Scan, 2 μg/mL IV, 185MBq | 0 | 3 | 0 | 3 | 1 | 3 |
| EG003 | Parkinson's Disease | Parkinson's Disease GE180 PET Scan, 2 μg/mL IV, 185MBq | 0 | 4 | 0 | 4 | 0 | 4 |
| Mild Nausea | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Regression, Linear |
F=0.447 |
| 0.53 |
| Other |
Linear Regression |
| Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in Control Subjects | Regression, Linear | F=1.773 | 0.23 | Other | Linear Regression |
| Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in Control Subjects | Regression, Linear | F=3.615 | 0.01 | Other | Linear Regression |
| Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in MCI Subjects | Regression, Linear | F=9.204 | 0.039 | Other | Linear Regression |
| Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in MCI Subjects | Regression, Linear | F=1.209 | 0.33 | Other | Linear Regression |
| Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in MCI Subjects | Regression, Linear | F=5.801 | 0.07 | Other | Linear Regression |
| Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in MCI Subjects | Regression, Linear | F=10.374 | 0.03 | Other | Linear Regression |
| Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in AD Subjects | Regression, Linear | F=5.024 | 0.27 | Other | Linear Regression |
| Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in AD Subjects | Regression, Linear | F=15.568 | 0.16 | Other | Linear Regression |
| Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in AD Subjects | Regression, Linear | F=5.238 | 0.262 | Other | Linear Regression |
| Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in AD Subjects | Regression, Linear | F=221.308 | 0.043 | Other | Linear Regression |
| Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in PD Subjects | Regression, Linear | F=2.430 | 0.26 | Other | Linear Regression |
| Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in PD Subjects | Regression, Linear | F=1.269 | 0.38 | Other | Linear Regression |
| Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in PD Subjects | Regression, Linear | F=13.164 | 0.07 | Other | Linear Regression |
| Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in PD Subjects | Regression, Linear | F=1.312 | 0.37 | Other | Linear Regression |
| Regression, Linear |
F=0.011 |
| 0.92 |
| Other |
Linear Regression |
| Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in Control Subjects | Regression, Linear | F=1.790 | 0.22 | Other | Linear Regression |
| Linear Regression of Language Composite Scores and Parietal GE180 SUVR in Control Subjects | Regression, Linear | F=0.720 | 0.42 | Other | Linear Regression |
| Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in MCI Subjects | Regression, Linear | F=0.305 | 0.61 | Other | Linear Regression |
| Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in MCI Subjects | Regression, Linear | F=0.005 | 0.95 | Other | Linear Regression |
| Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in MCI Subjects | Regression, Linear | F=0.435 | 0.55 | Other | Linear Regression |
| Linear Regression of Language Composite Scores and Parietal GE180 SUVR in MCI Subjects | Regression, Linear | F=0.787 | 0.43 | Other | Linear Regression |
| Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in AD Subjects | Regression, Linear | F=316.379 | 0.036 | Other | Linear Regression |
| Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in AD Subjects | Regression, Linear | F=2.032 | 0.39 | Other | Linear Regression |
| Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in AD Subjects | Regression, Linear | F=425.337 | 0.031 | Other | Linear Regression |
| Linear Regression of Language Composite Scores and Parietal GE180 SUVR in AD Subjects | Regression, Linear | F=4.739 | 0.274 | Other | Linear Regression |
| Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in PD Subjects | Regression, Linear | F=0.263 | 0.66 | Other | Linear Regression |
| Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in PD Subjects | Regression, Linear | F=12.244 | 0.07 | Other | Linear Regression |
| Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in PD Subjects | Regression, Linear | F=0.762 | 0.48 | Other | Linear Regression |
| Linear Regression of Language Composite Scores and Parietal GE180 SUVR in PD Subjects | Regression, Linear | F=7.107 | 0.12 | Other | Linear Regression |
| Regression, Linear |
F=0.042 |
| 0.84 |
| Other |
Linear Regression |
| Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in Control Subjects | Regression, Linear | F=1.021 | 0.35 | Other | Linear Regression |
| Linear Regression of Language Composite Scores and Temporal GE180 SUVR in Control Subjects | Regression, Linear | F=1.610 | 0.25 | Other | Linear Regression |
| Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in MCI Subjects | Regression, Linear | F=1.779 | 0.25 | Other | Linear Regression |
| Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in MCI Subjects | Regression, Linear | F=0.455 | 0.54 | Other | Linear Regression |
| Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in MCI Subjects | Regression, Linear | F=0.650 | 0.47 | Other | Linear Regression |
| Linear Regression of Language Composite Scores and Temporal GE180 SUVR in MCI Subjects | Regression, Linear | F=0.131 | 0.74 | Other | Linear Regression |
| Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in AD Subjects | Regression, Linear | F=0.075 | 0.83 | Other | Linear Regression |
| Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in AD Subjects | Regression, Linear | F=1.831 | 0.41 | Other | Linear Regression |
| Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in AD Subjects | Regression, Linear | F=0.079 | 0.83 | Other | Linear Regression |
| Linear Regression of Language Composite Scores and Temporal GE180 SUVR in AD Subjects | Regression, Linear | F=0.879 | 0.52 | Other | Linear Regression |
| Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in PD Subjects | Regression, Linear | F=0.001 | 0.98 | Other | Linear Regression |
| Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in PD Subjects | Regression, Linear | F=0.005 | 0.95 | Other | Linear Regression |
| Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in PD Subjects | Regression, Linear | F=1.733 | 0.32 | Other | Linear Regression |
| Linear Regression of Language Composite Scores and Temporal GE180 SUVR in PD Subjects | Regression, Linear | F=0.249 | 0.67 | Other | Linear Regression |
| Regression, Linear |
F=0.513 |
| 0.49 |
| Other |
Linear Regression |
| Linear Regression of DRS Scores and Whole Brain GE180 SUVR in MCI Subjects | Regression, Linear | F=0.008 | 0.93 | Other | Linear Regression |
| Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in MCI Subjects | Regression, Linear | F=0.430 | 0.54 | Other | Linear Regression |
| Linear Regression of DRS Scores and Whole Brain GE180 SUVR in AD Subjects | Regression, Linear | F=0.142 | 0.77 | Other | Linear Regression |
| Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in AD Subjects | Regression, Linear | F=0.496 | 0.61 | Other | Linear Regression |
| Linear Regression of DRS Scores and Whole Brain GE180 SUVR in PD Subjects | Regression, Linear | F=8.046 | 0.11 | Other | Linear Regression |
| Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in PD Subjects | Regression, Linear | F=0.051 | 0.84 | Other | Linear Regression |